Core Insights - Moderna reported a loss of $0.51 per share in Q3 2025, which was better than the Zacks Consensus Estimate of a loss of $2.15, compared to an EPS of $0.03 in the same period last year [1][10] - Total revenues for the quarter were $1.02 billion, exceeding the Zacks Consensus Estimate of $860 million, but representing a 45% decline year over year due to lower net product sales [1][10] Revenue Breakdown - Moderna has three marketed vaccines: Spikevax, mNexspike, and mResvia. Product sales fell nearly 47% year over year to $973 million [2] - Sales from COVID-19 vaccines amounted to $971 million, down 46% year over year, attributed to lower vaccination rates and the transition of COVID-19 to a seasonal market [2] - mResvia sales were only $2 million, significantly below the estimated $30 million, and down 80% year over year due to competition from GSK's Arexvy and Pfizer's Abrysvo [3] Operating Costs and Efficiency - SG&A expenses decreased by 5% year over year to $268 million, primarily due to cuts in consulting and external services [5] - R&D expenses were reduced by 30% to $801 million, reflecting a focus on efficiency and prioritization of clinical development [5] Guidance and Outlook - Moderna revised its total revenue guidance for 2025 to a range of $1.6-$2.0 billion, down from $1.5-$2.2 billion [6] - The company also lowered its R&D expense guidance to $3.3-$3.4 billion, from a previous estimate of $3.6-$3.8 billion, while maintaining SG&A and capital expenditure guidance at approximately $1.1 billion and $0.3 billion, respectively [7] Market Reaction - Shares of Moderna rose by 10% in pre-market trading, likely due to the company's cost-cutting measures and improved liquidity outlook, now projected to be between $6.5-$7.0 billion by year-end 2025 [8] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, including a personalized cancer therapy in collaboration with Merck [12][16] - The company discontinued development of mRNA-1647 for CMV prevention after failing to meet primary efficacy endpoints but continues to study it in mid-stage trials for bone marrow transplant patients [13] - Positive results from a phase III study for mRNA-1010, a standalone influenza vaccine, have led to plans for regulatory submissions in early 2026 [14] - The company is also working on mRNA-1083, a combination vaccine for COVID-19 and influenza, and is awaiting further guidance from the FDA [15]

Core Insights - Moderna (MRNA) is expected to report Q3 2025 earnings on November 6, with sales estimated at $860 million and a loss of $2.15 per share, indicating a significant decline from the previous year [1] - The consensus estimate for loss per share has widened from $9.50 to $9.74 over the past month [1] Earnings Performance - Moderna has beaten earnings estimates in the last four quarters, with an average surprise of 37.78%, including a 28.76% surprise in the last reported quarter [2][3] Revenue Expectations - The majority of Q3 revenues are anticipated to come from COVID-19 vaccines, with combined sales estimated at $762 million, reflecting a significant decline due to reduced demand for boosters [5][6] - Minimal sales of the RSV vaccine, mResvia, are expected at $30 million, significantly lower than competitors GSK's Arexvy and Pfizer's Abrysvo [7] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, with a focus on updates following the recent setback in the CMV vaccine program [8] - The pivotal Phase III study for mRNA-1647 failed to meet primary efficacy endpoints, leading to its discontinuation, although it continues to be studied in mid-stage trials [9] - Investors are also focused on mRNA-1083, a COVID-19/influenza combination vaccine, which is on track for FDA resubmission [10] - Intismeran autogene, a personalized cancer therapy developed with Merck, is undergoing pivotal studies, and updates on its progress are anticipated [11] Stock Performance and Valuation - Year-to-date, Moderna's shares have decreased by 40%, underperforming the industry and the S&P 500 [13][14] - The stock is trading at a premium valuation, with a price/sales ratio of 3.14 compared to the industry average of 2.33 [16] Investment Outlook - Despite significant declines in revenue, Moderna's cash position of approximately $7.5 billion allows for continued investment in pipeline development [18] - The recent CMV vaccine setback has raised concerns about the company's growth trajectory and reliance on other late-stage assets [19][20] - Plans to launch 10 new marketed products by 2028 targeting a market exceeding $30 billion are now clouded by the CMV failure and underwhelming sales of mResvia [21] - Current premium valuation and downward revisions to earnings estimates suggest caution for investors considering building positions in Moderna stock [22]

Core Insights - Moderna's annual sales from its COVID-19 vaccine have significantly declined from over $18 billion, leading to a drop in revenue, earnings, and stock price [1] - The company aims to demonstrate that its success is sustainable, with potential for substantial stock-market returns in the next five years [1] Group 1: Clinical Progress and Pipeline - Moderna's mRNA platform enables faster vaccine development compared to traditional methods, bolstered by increased R&D spending from COVID vaccine profits [3] - Recent clinical and regulatory achievements include the approval of the RSV vaccine, mResvia [4] - The company is focusing on mRNA-4157, a personalized cancer vaccine, which has shown promising results in mid-stage studies for melanoma when combined with Merck's Keytruda [5] - mRNA-4157 is currently in phase 3 trials and is being tested for various cancers, indicating potential for significant future success [6] Group 2: Market Outlook - Despite recent challenges, Moderna's pipeline could lead to improved financial results and stock performance, suggesting that patient investors may see gains in the future [7] - The stock has underperformed due to lackluster financial results, but advancements in the pipeline could enhance its value over the next five years [9]

Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]

Core Insights - GSK plc is a significant player in the global vaccine market, focusing on vaccines for various infectious diseases [1] Group 1: Vaccine Sales Performance - GSK's vaccine sales in the United States are declining, particularly for the shingles vaccine Shingrix and the RSV vaccine Arexvy, due to a challenging external environment [2] - In the first half of 2025, U.S. sales of Shingrix and Arexvy fell by 56% and 18% respectively, contributing to an overall 11% decline in total vaccine sales at constant exchange rates (CER) [4] - Despite slight improvements in the second quarter of 2025 due to higher sales in Europe, challenges in the U.S. and other international markets are expected to persist [5] Group 2: Regulatory Impact - Revised recommendations from the U.S. Advisory Committee on Immunization Practices (ACIP) in June 2024 have negatively impacted Arexvy's sales, limiting its use for adults aged 50-74 to those at increased risk of severe RSV disease [3][10] Group 3: Pipeline and Future Prospects - GSK has a promising pipeline, including the recently approved pentavalent meningococcal vaccine Penmenvy, which could enhance immunization schedules [6] - The company is also developing vaccines for measles, mumps, rubella, varicella, and various mRNA vaccines, although these will take time to contribute to sales [6] Group 4: Competitive Landscape - Other companies, such as Pfizer and Moderna, have also entered the RSV vaccine market, with their products gaining traction following initial approvals [7] - GSK's RSV vaccine is approved for high-risk individuals aged 50-59, while competitors have broader approvals for younger high-risk populations [8] Group 5: Financial Performance and Valuation - GSK's stock has increased by 19.2% year-to-date, outperforming the industry, which saw a slight decrease of 0.1% [9] - The company's shares are trading at a forward price/earnings ratio of 8.68, which is lower than the industry average of 14.78 and below its 5-year mean of 10.05 [11] - Earnings estimates for 2025 and 2026 have seen slight upward revisions, indicating potential for future growth [13]

Core Insights - Moderna reported a Q2 2025 loss of $2.13 per share, which was better than the Zacks Consensus Estimate of a loss of $2.99, and an improvement from a loss of $3.33 in the same period last year [1][7] - Total revenues for the quarter were $142 million, exceeding the Zacks Consensus Estimate of $127 million, but reflecting a 41% year-over-year decline due to lower net product sales [1][2] - The company revised its total revenue guidance for 2025 to a range of $1.5 billion to $2.2 billion, a reduction of $300 million from the previous guidance [5][9] Revenue Breakdown - Product sales decreased by 38% year over year to $114 million, primarily due to lower sales of the COVID-19 vaccine Spikevax, with minimal contribution from the newly launched RSV vaccine mResvia [2][3] - Moderna generated $28 million from grants, collaborations, licensing, and royalty revenues, down 51% year over year, typically derived from partnerships with major pharma companies [3] Cost Management - Selling, general and administrative (SG&A) expenses were $230 million, a 14% decrease year over year, attributed to cost-cutting measures [4] - Research and development (R&D) expenses fell by 43% to $700 million, influenced by reduced clinical spending across respiratory programs [4][9] Future Outlook - The company anticipates generating the majority of its guided revenue in the second half of 2025, with a revenue split of 40-50% expected in Q3 [8] - Moderna expects to end 2025 with nearly $6 billion in cash, cash equivalents, and investments [10] Pipeline Developments - Moderna received three regulatory approvals from the FDA, including full approval for Spikevax in pediatric patients and label expansion for mResvia [11] - The company is evaluating several late-stage pipeline candidates, including a promising influenza vaccine candidate, mRNA-1010, which showed superior efficacy compared to an approved flu shot [12][13] - A significant candidate in development is intismeran autogene, a personalized cancer therapy being evaluated in collaboration with Merck [14][16] Legal Developments - The U.K. Court of Appeal upheld the validity of Moderna's EP'949 patent, affirming the infringement by Pfizer/BioNTech's COVID-19 vaccine Comirnaty [17]

Core Viewpoint - Moderna (MRNA) is expected to exceed earnings expectations for Q2 2025, with a prior earnings surprise of 13.70% in the last quarter. The consensus estimates for sales and earnings are $127 million and a loss of $2.99 per share, respectively [1][9]. Factors Shaping MRNA's Upcoming Results - A significant portion of Moderna's revenue is anticipated to come from the COVID-19 vaccine, Spikevax, with estimated sales of $59 million, reflecting a notable decline from the previous year due to reduced demand [2]. - Minimal sales are expected from the RSV vaccine, mResvia, with projections of only $2 million, which is considerably lower than competing products from GSK and Pfizer. This is attributed to the later approval and recommendation of the vaccine [3]. Regulatory Developments - The FDA has expanded the label for mResvia to include high-risk adults aged 18-59, and the CDC has updated its recommendations for RSV vaccines to include high-risk adults aged 50-59. Investors are looking for updates on marketing strategies for both vaccines [4]. - A regulatory filing is under FDA review to update Spikevax for the LP.8.1 variant for the 2025-26 vaccination season, with a similar filing also under review by the EMA. Investors are keen on updates regarding these regulatory processes [5]. Pipeline Candidates - Moderna is advancing several late-stage pipeline candidates, including the influenza vaccine candidate mRNA-1010, which has shown superior efficacy compared to an approved flu shot. This supports potential approval for a standalone flu shot and strengthens the case for the combination vaccine mRNA-1083 [6]. - An important candidate is intismeran autogene, a personalized cancer therapy developed in collaboration with Merck, currently evaluated in pivotal phase III studies for various cancer indications. Investors are interested in updates on this therapy's progress [7]. Earnings Surprise History - Moderna has consistently beaten earnings estimates over the past four quarters, achieving an average surprise of 31.60% [8]. Market Performance - Year to date, Moderna's shares have declined by 18%, contrasting with a 2% growth in the industry [10].

Core Insights - GSK's RSV vaccine, Arexvy, has received FDA acceptance for expanded use in high-risk adults under 50, with a final decision expected in the first half of 2026 [1][2] - Arexvy is currently approved for individuals aged 60 and older, and for high-risk individuals aged 50-59, and if approved for the younger demographic, it will be the third FDA-approved RSV vaccine for this age group [2][9] - GSK's stock has performed well, gaining 13% year-to-date compared to a 1% decline in the industry [4] Regulatory Developments - A similar regulatory filing for Arexvy was accepted by the EMA, with approval anticipated early next year [3] - The filing is backed by late-stage study data demonstrating Arexvy's safety profile consistent with previous studies [2][8] Sales Performance - Arexvy's sales declined by 51% year-over-year to £590 million (approximately $755 million) in full-year 2024, primarily due to narrower vaccination recommendations from the U.S. Advisory Committee on Immunization Practices (ACIP) [6][8] - The ACIP recommended Arexvy for adults aged 75 and older, but limited vaccination for those aged 60-74 to individuals at increased risk, reducing the eligible population [7][8] Competitive Landscape - GSK's competitive position has weakened as Pfizer and Moderna have gained broader regulatory approvals for their RSV vaccines, covering high-risk individuals aged 18-74 [9] - The CDC has updated guidelines to recommend vaccination for high-risk adults aged 50-59, a group for which Arexvy is already approved, improving the outlook for the upcoming RSV season [10] - All three vaccine-makers, GSK, Pfizer, and Moderna, are on relatively equal footing due to the absence of CDC guidance for high-risk adults under 50, with pending regulatory decisions likely to influence market dynamics [11]

Core Viewpoint - The U.S. CDC has adopted new recommendations for RSV vaccinations, lowering the age for eligible recipients, which has positively impacted Moderna's stock price and expanded its market potential for the RSV vaccine, mResvia [1][7]. Group 1: CDC Recommendations - The CDC has revised its recommendations to include adults aged 50-59 at higher risk of severe illness from RSV, advising them to receive a single dose of the vaccine [2][8]. - Previously, the guidance recommended vaccination for individuals aged 75 and older, and those aged 60-74 who were at high risk [2][8]. - The current HHS secretary, Robert F. Kennedy, Jr., officially adopted these recommendations, filling the role of CDC director, which is currently vacant [3]. Group 2: Impact on Moderna - The expanded CDC recommendations increase the addressable market for Moderna's RSV vaccine, mResvia, by including a new segment of eligible patients aged 50-59 [7][8]. - Despite the initial approval of mResvia for individuals aged 60 and older, the FDA recently expanded its label to include high-risk individuals aged 18-59 [9]. - Sales of mResvia have been modest since its commercial launch last year, as it was approved later in the contracting season compared to GSK's and Pfizer's vaccines [9][10]. Group 3: Competitive Landscape - Moderna is competing with GSK and Pfizer, both of which have already received approvals for their RSV vaccines for individuals aged 60 and older, with GSK's Arexvy also approved for high-risk individuals aged 50-59, and Pfizer's Abrysvo approved for high-risk individuals aged 18-59 [11]. - The earlier availability of GSK and Pfizer's vaccines has given them a dominant position in the market over Moderna [10]. Group 4: Stock Performance - Year to date, Moderna's stock has lost 27%, while the industry has only seen a 2% decline [5].

Group 1: Regulatory Developments - GSK announced that the European Medicines Agency (EMA) has accepted the regulatory application for the expanded use of its RSV vaccine, Arexvy, for adults aged 18 years and above, with a final decision expected in the first half of 2026 [1] - Arexvy is currently approved for individuals aged 60 years and above and high-risk individuals aged 50-59 years [2][7] Group 2: Sales Performance - Arexvy generated sales of £78 million in the first quarter of 2025, reflecting a 57% year-over-year decline due to lower demand in the United States [8][7] - Year to date, GSK shares have risen 20.8%, contrasting with a 0.6% decline in the industry [4] Group 3: Market Context - Other RSV vaccine makers include Pfizer's Abrysvo, which is approved for individuals aged 60 years and above and high-risk adults aged 18-59 years [9] - Moderna's RSV vaccine, mResvia, was approved for older adults and is also being expanded for high-risk adults aged 18-59 years [11] - The overall RSV vaccine market has seen weak sales for the 2024-2025 vaccination season, attributed to restrictive recommendations from the U.S. CDC [12]